Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project

C Willame, C Dodd, L van der Aa, G Picelli, HD Emborg, J Kahlert, R Gini, C Huerta, E Martin-Merino, C McGee, S de Lusignan, G Roberto, M Villa, Daniel Weibel, L Titievsky, M Sturkenboom

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Introduction: The public–private ADVANCE collaboration developed and tested a system to generate evidence on vaccine benefits and risks using European electronic healthcare databases. In the safety of vaccines, background incidence rates are key to allow proper monitoring and assessment. The goals of this study were to compute age-, sex-, and calendar-year stratified incidence rates of nine autoimmune diseases in seven European healthcare databases from four countries and to assess validity by comparing with published data. Methods: Event rates were calculated for the following outcomes: acute disseminated encephalomyelitis, Bell’s palsy, Guillain–Barré syndrome, immune thrombocytopenia purpura, Kawasaki disease, optic neuritis, narcolepsy, systemic lupus erythematosus, and transverse myelitis. Cases were identified by diagnosis codes. Participating organizations/databases originated from Denmark, Italy, Spain, and the UK. The source population comprised all persons registered, with at least 1 year of data prior to the study start, or follow-up from birth. Stratified incidence rates were computed per database over the period 2003 to 2014. Results: Between 2003 and 2014, 148,947 incident cases of nine autoimmune diseases were identified. Crude incidence rates were highest for Bell’s palsy [23.8/100,000 person-years (PYs), 95% confidence interval (CI) 23.6–24.1] and lowest for Kawasaki disease (0.7/100,000 PYs, 95% CI 0.6–0.7). Specific patterns were observed by sex, age, calendar time, and data sources. Rates were comparable with published estimates. Conclusion: A range of autoimmune events could be identified in the ADVANCE system. Estimation of rates indicated consistency across selected European healthcare databases, as well as consistency with US published data.

Original languageEnglish
Pages (from-to)383-395
Number of pages13
JournalDrug Safety
Issue number3
Publication statusPublished - 19 Jan 2021

Bibliographical note

Funding Information:
The Innovative Medicines Initiative Joint Undertaking funded this project under ADVANCE Grant agreement number 115557, resources of which were composed of a financial contribution from the European Union’s Seventh Framework Programme (FP7/2007–2013) and in kind contributions from European Federation of Pharmaceutical Industries and Associations (EFPIA) member companies.

Publisher Copyright:
© 2021, The Author(s).

Research programs

  • EMC OR-01


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